Quality Control Lead
Job Summary
Overview:
We are seeking a Quality Control Lead to oversee a team of inspectors in a fast-paced production environment. Reporting directly to the Manager, Quality Control.
Key Responsibilities
Ensure compliance with quality system requirements for medical devices at Cook Medical.
1. Inspect raw materials, in-process products, finished and sterilized devices to maintain high standards.
2. Develop or review SOPs, manufacturing and quality control instructions, as required by the quality team.
3. Maintain a clean and organized workspace to prevent product contamination.
4. Communicate changes to procedures or instructions to affected personnel in production.
5. Identify training needs for employees in the QC area and provide necessary training.
6. Monitor employee performance, conduct performance appraisals, and implement improvement plans as needed.
7. Foster excellent communication between production teams and other departments.
8. Collaborate with other departments to meet delivery requirements.
9. Investigate customer complaints, CAPAs, and determine root cause.
10. Manage rejects from quality control processes through the MRB process.
11. Uphold Cook's Code of Conduct in all business matters.
Requirements
Bachelor's degree in Manufacturing Engineering or related field (preferable).
12. Minimum 5 years of experience in a supervisory position (desirable).
13. Strong communication and interpersonal skills.
14. Knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
15. Knowledge of Lean Manufacturing is an asset.
16. Proficiency in Microsoft Office and computer skills.
17. Excellent organizational and team-building skills.
18. High self-motivation and willingness to travel for company business.